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April 23, 2001

Drug-Related Adverse Events: A Readers' Guide to Assessing Literature Reviews and Meta-analyses

Author Affiliations

Copyright 2001 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2001

Arch Intern Med. 2001;161(8):1041-1046. doi:10-1001/pubs.Arch Intern Med.-ISSN-0003-9926-161-8-icx00012

IN THE SETTING of increasing concern about drug safety and a burgeoning literature on the subject, the objective of this article is to provide readers with a practical guide to critically appraising reviews and meta-analyses of source studies of drug-related adverse events. A critique of a recent highly publicized meta-analysis of adverse drug reactions is used as a case study here to highlight several contentious issues. The published literature on drug-related adverse events is fraught with problems, starting with the original reports and extending to systematic reviews and meta-analyses thereof. A fundamental and universal taxonomy does not exist. For original reports, prospective protocols are missing; event ascertainment is poorly described and executed; and analytic methods are questionable and lead to problems of imprecise estimates, multiple correlations, and generalizability of results. It is recommended that for reviews and syntheses of original reports, explicit search methods and study selection criteria are needed. Special attention must be paid to choice of analytic methods; to approaches to inconsistent reporting formats and heterogeneity and bias in the selected studies; and to problems of imprecise estimates, multiple correlations, and interpretation and generalizablility of results. In conclusion, systematic reviews and meta-analyses of reports of drug-related adverse events must be considered, with special attention to source materials and methods. It is well worth the effort to do so, since, on balance, systematic review and meta-analytic techniques hold great promise for pharmacovigilance efforts.